Last week, the American College of Rheumatology (ACR) published a new white paper “encourag[ing] providers to incorporate [biosimilars] into the treatment plans of patients with rheumatic diseases where appropriate.”
The paper, titled “The Science Behind Biosimilars — Entering a New Era of Biologic Therapy,” discusses the regulatory regime for biosimilars, “scientific aspects of manufacturing” biologic drugs, the drug-substitution context for biosimilars, and the “economics of biosimilars and patient access.” The paper notes that while “[t]he initial position of the ACR on biosimilars supported the rationale behind pursuing biosimilars, but urged caution as they were being developed, evaluated, and approved,” now that “biosimilars have been used successfully in Europe, with rigorously acquired data supporting their broader use, and as the US is on the verge of a similar transition, the ACR is poised to reconsider its position.” The ACR recommends: “Health care providers should now incorporate biosimilars, where appropriate, into regimens to treat patients with rheumatologic diseases. It is important to maintain a working knowledge of approved biosimilars and to monitor evolving policies and guidelines regarding the development and use of new biosimilars.”
The ACR press release and paper note that of the nine biosimilar medications FDA has approved, six are for the treatment of rheumatic diseases. The organization has also issued other statements on biosimilars, including, as we covered in an earlier post, a letter submitted to FDA in response to FDA’s comments regarding existing requirements for biologics and biosimilars.